IMM60 and Pembrolizumab in Melanoma and NSCLC

NCT ID: NCT05709821

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-04-22

Brief Summary

The goal of this clinical trial is to learn about IMM60 with or without pembrolizumab in participants with advanced melanoma or non-small cell lung cancer. There are two phases:

• Phase 1: This phase is designed to learn about the safety of IMM60 with or without pembrolizumab and to find a safe dose to test in Phase 2.
• Phase 2: This phase is designed to learn whether IMM60 + pembrolizumab improves progression-free survival at 12 months compared to pembrolizumab alone in participants with non-small cell lung cancer.

Detailed Description

This exploratory phase 1/phase 2 study is designed to establish a recommended phase 2 dose of IMM60 and provide preliminary estimates of safety and efficacy of IMM60 alone and in combination with pembrolizumab in participants with NSCLC and melanoma. In phase 1, initial safety will be assessed in a multiple dose escalation cohort for IMM60 alone, then for the IMM60 + pembrolizumab combination. Phase 2 of the study will recruit PD-1 pretreated melanoma participants and randomize PD-L1 > 50% total NSCLC participants 2:1 to IMM60 + pembrolizumab vs pembrolizumab alone. There is an additional cohort of PD-L1 < 1% NSCLC participants.

Conditions

Non-small Cell Lung Cancer; Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 IMM60 dose escalation safety arm

3 dose levels of IMM60 will be assessed (1, 3, 9 and 36 mg/m\^2 administered IV every 3 weeks for up to 6 cycles)

Group Type: EXPERIMENTAL

IMM60

Intervention Type: DRUG

IMM60, every 3 weeks for up to 6 cycles, intravenous (IV) infusion

Phase 1 IMM60 + pembrolizumab combination safety arm

Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles will be administered in combination with IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the IMM60 dose escalation safety cohort.

Group Type: EXPERIMENTAL

IMM60

Intervention Type: DRUG

IMM60, every 3 weeks for up to 6 cycles, intravenous (IV) infusion

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab, 200 mg, every 3 weeks for up to 35 cycles or approximately 2 years, intravenous (IV) infusion

Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, IMM60 + pembrolizumab)

Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles will be administered in combination with IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation safety cohorts.

Group Type: EXPERIMENTAL

IMM60

Intervention Type: DRUG

IMM60, every 3 weeks for up to 6 cycles, intravenous (IV) infusion

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab, 200 mg, every 3 weeks for up to 35 cycles or approximately 2 years, intravenous (IV) infusion

Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, pembrolizumab monotherapy)

Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles.

Group Type: ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab, 200 mg, every 3 weeks for up to 35 cycles or approximately 2 years, intravenous (IV) infusion

Phase 2 PD-L1 <1% NSCLC Cohort 2

Participants will be treated with one cycle of IMM60 with a tumor biopsy before and after, to determine any changes in PD-L1 expression. After this one cycle, the participants will receive the combination of IMM60 IV for up to 6 total cycles + pembrolizumab 200 mg every 3 weeks administered IV. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation cohorts.

Group Type: EXPERIMENTAL

IMM60

Intervention Type: DRUG

IMM60, every 3 weeks for up to 6 cycles, intravenous (IV) infusion

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab, 200 mg, every 3 weeks for up to 35 cycles or approximately 2 years, intravenous (IV) infusion

Melanoma Cohort

IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation cohorts.

Group Type: EXPERIMENTAL

IMM60

Intervention Type: DRUG

IMM60, every 3 weeks for up to 6 cycles, intravenous (IV) infusion

Interventions

IMM60

IMM60, every 3 weeks for up to 6 cycles, intravenous (IV) infusion

Intervention Type: DRUG

Pembrolizumab

Pembrolizumab, 200 mg, every 3 weeks for up to 35 cycles or approximately 2 years, intravenous (IV) infusion

Intervention Type: DRUG

Other Intervention Names

PORT-2; KEYTRUDA®

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 to 1
• Adequate organ function
• At least 1 lesion, not previously irradiated, that can be accurately measured on CT or MRI as defined by RECIST 1.1 criteria
• NSCLC cohorts: Histologically confirmed diagnosis of stage IV NSCLC
• NSCLC cohorts: Patients with adenocarcinoma histology must not have sensitizing epidermal growth factor receptor (EGFR) or ROS proto-oncogene 1 (ROS1) mutations or anaplastic lymphoma kinase (ALK) translocations
• NSCLC cohorts: Participants in NSCLC arms must have a PD-L1 assessment (PD-L1 immuno-histochemistry (IHC) 22C3 pharmDx)
• Melanoma cohorts: Unresectable stage III or IV, histologically confirmed diagnosis of cutaneous or unknown primary melanoma
• Melanoma cohorts: B-type Raf proto-oncogene (BRAF) mutation status available
• Male participants: Participant must agree to use contraception and refrain from sperm donation during the treatment period and for at least 120 days after the last dose of study intervention
• Female participants: Participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

1. Not a woman of childbearing potential (WOCBP)

2. A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 6 months after the last dose of study intervention

Exclusion Criteria

• Has the following cardiac conditions:

1. Corrected QT interval (QTc) > 450 ms

2. Uncontrolled hypertension with blood pressure (BP) > 160/100 despite treatment

3. Class II or greater heart failure as defined by the New York Heart Association

4. Myocardial infarction within 6 months or angina requiring nitrate therapy more than once a week

• Another active malignancy within the past 2 years (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded. Also, prostate, breast, and neuroendocrine tumors that are stable on hormonal treatment for a period of 1 year or more without the need to adjust dose are not excluded.)
• Has had an allogeneic tissue/solid organ transplant
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
• History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Participants with an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids (in dosing exceeding 10 mg daily of prednisone equivalent) or immunosuppressive agents.
• Participants who are known to be serologically positive for Hepatitis B, Hepatitis C, or human immunodeficiency virus.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

iOx Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Dana-Farber Cancer Institute - Medicine

Boston, Massachusetts, United States

Henry Ford Hospital - Internal Medicine

Detroit, Michigan, United States

Rutgers, The State University of New Jersey - Robert Wood Johnson Medical School - The Cancer Institute of New Jersey (CINJ)

New Brunswick, New Jersey, United States

Next VA

Fairfax, Virginia, United States

Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Complexo Hospitalario Universitario A Coruña

A Coruña, Galicia, Spain

Hospital Xeral Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Regional Universitario de Málaga

Málaga, , Spain

Hospital Universitario Virgen De La Macarena

Seville, , Spain

H. Clínico de Valencia

Valencia, , Spain

Nottingham University Hospital - Oncology

Nottingham, , United Kingdom

Countries

United States; Spain; United Kingdom

Other Identifiers

KEYNOTE-E69

Identifier Type: OTHER

Identifier Source: secondary_id

2022-003310-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IMPORT-201

Identifier Type: -

Identifier Source: org_study_id